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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00306137




Registration number
NCT00306137
Ethics application status
Date submitted
21/03/2006
Date registered
23/03/2006
Date last updated
9/12/2014

Titles & IDs
Public title
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
Scientific title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
Secondary ID [1] 0 0
EudraCT: 2005-004689-18
Secondary ID [2] 0 0
11800
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Loss, Surgical 0 0
Condition category
Condition code
Cancer 0 0 0 0
Oesophageal (gullet)
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trasylol (Aprotinin, BAYA0128)
Treatment: Drugs - Placebo

Experimental: Arm 1 -

Placebo comparator: Arm 2 -


Treatment: Drugs: Trasylol (Aprotinin, BAYA0128)
Subjects successfully meeting all screening criteria will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.

Subjects will be stratified into one of the 4 following strata:

* Stratum 1: complete primary pneumonectomy
* Stratum II: decortication or completion pneumonectomy
* Stratum III: esophagectomy by transhiatal approach
* Stratum IV: esophagectomy by transthoracic approach

Treatment: Drugs: Placebo
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
Timepoint [1] 0 0
Up to the end of follow up visit (4 to 8 weeks)
Secondary outcome [1] 0 0
Number of units of blood or packed red cells transfused
Timepoint [1] 0 0
Up to the end of follow up visit (4 to 8 weeks)
Secondary outcome [2] 0 0
Number of units transfused per patient
Timepoint [2] 0 0
Up to the end of follow up visit (4 to 8 weeks)
Secondary outcome [3] 0 0
Intra-operative blood loss
Timepoint [3] 0 0
Intra-operative
Secondary outcome [4] 0 0
Drainage volume
Timepoint [4] 0 0
Until removal of drains
Secondary outcome [5] 0 0
Transfusion of platelets, colloids and plasma
Timepoint [5] 0 0
Up to the end of follow up visit (4 to 8 weeks)
Secondary outcome [6] 0 0
Change from pre-operative to post-operative hemoglobin concentration
Timepoint [6] 0 0
At day 3 or earlyer prior to transfusion
Secondary outcome [7] 0 0
Surgeon's assessment of obscurement of operative field by bleeding
Timepoint [7] 0 0
Up to the end of follow up visit (4 to 8 weeks)
Secondary outcome [8] 0 0
Blood markers of inflammation and coagulation
Timepoint [8] 0 0
Up to the end of follow up visit (4 to 8 weeks)
Secondary outcome [9] 0 0
Time to discontinuation of mechanical ventilation
Timepoint [9] 0 0
Until removal of mechanical ventilation
Secondary outcome [10] 0 0
Health related quality of life measurements
Timepoint [10] 0 0
Up to the end of follow up visit (4 to 8 weeks)

Eligibility
Key inclusion criteria
* Men or women 18 years of age and older
* Subjects requiring protocol specified oncological surgery. Subjects must have histological confirmation of malignancy in lung or esophagus
* Documented, signed and dated informed consent obtained prior to any study specific procedures being performed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
* Subjects undergoing laparoscopic surgery
* Subjects with sepsis or mesothelioma
* Subjects with impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter)
* Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have.
* Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of <24% or hemoglobin of <8 g/dl)
* Subjects who have participated in an investigational drug study within the past 30 days
* Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception
* Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
* Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- ask Contact
Recruitment postcode(s) [1] 0 0
- ask Contact
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Austria
State/province [11] 0 0
ask Contact
Country [12] 0 0
Belgium
State/province [12] 0 0
ask Contact
Country [13] 0 0
Canada
State/province [13] 0 0
ask Contact
Country [14] 0 0
Denmark
State/province [14] 0 0
ask Contact
Country [15] 0 0
France
State/province [15] 0 0
ask Contact
Country [16] 0 0
Germany
State/province [16] 0 0
ask Contact
Country [17] 0 0
Spain
State/province [17] 0 0
ask Contact
Country [18] 0 0
United Kingdom
State/province [18] 0 0
ask Contact

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
Trial website
https://clinicaltrials.gov/study/NCT00306137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00306137